Esomeprazole sodium freeze-dried powder and preparation method thereof

The invention discloses esomeprazole sodium freeze-dried powder and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The esomeprazole sodium freeze-driedpowder is composed of esomeprazole sodium, disodium hydrogen phosphate and sodium hydroxide, wherein...

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Hauptverfasser: WANG QINGPENG, SHANG YUNFEI, LUO XIANLI, YANG YONGXIA, WANG YUTUO
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The invention discloses esomeprazole sodium freeze-dried powder and a preparation method thereof, belonging to the technical field of pharmaceutical preparations. The esomeprazole sodium freeze-driedpowder is composed of esomeprazole sodium, disodium hydrogen phosphate and sodium hydroxide, wherein the mass of the esomeprazole sodium is 42.5mg; the addition amount of the disodium hydrogen phosphate is 0.3-0.8% of the mass of the esomeprazole sodium; and the sodium hydroxide is a pH regulator, so that the pH value of the solution of the freeze-dried powder is 10.5-11.0 before freeze frying. The technical scheme of the invention is mainly characterized in that the preparation formula is simple, excipients, antioxidants and other auxiliary materials are not needed, disodium hydrogen phosphate can achieve effects of a complexing agent and can also achieve pH buffering effect, and the stability of the finished preparation is ensured. According to the technical scheme in the invention, excessive dosing is not neede